Regulatory Actions for Unsponsored HPV Chemicals

In the HPV Challenge Program, companies agreed to provide basic hazard information on ("sponsored") more than 2,200 HPV chemicals. About 1,400 chemicals were sponsored directly through EPA's HPV Challenge Program and over 860 chemicals were sponsored indirectly through international efforts. Other chemicals, however, remained unsponsored in the voluntary program (6 pp., 42 KB, About PDF). Basic hazard data for these unsponsored chemicals are being obtained through regulatory efforts, such as TSCA section 4 test rules and TSCA section 8(a) (production and use) and 8(d) (unpublished health and safety studies) rules. EPA is also initiating actions, such as significant new use rules (SNUR), to manage risks from HPV unsponsored chemicals.

One way to collect additional chemical information is through
TSCA section 4 test rules. In order to issue a TSCA Section 4 test rule, certain risk-based and/or exposure-based findings for a chemical must be made as required by statute. EPA has used this authority in several rulemakings.

Final Test Rule for the First Group of Unsponsored HPV Chemicals (HPV1)

The first TSCA section 4 test rule to collect chemical data for unsponsored HPV chemicals was issued on March 16, 2006 (71 FR 13708). This final rule required 52 manufacturers and processors of 17 HPV chemicals to conduct screening-level tests to collect data on the chemicals' physical and chemical properties, toxic effects, and environmental fate. (On December 8, 2006, EPA issued a direct final rule that revoked testing requirements for one of the chemicals subject to the test rule (71 FR 71058).)

The data obtained under the first test rule has provided critical information about 16 unsponsored HPV chemicals, which will better enable the Agency to evaluate the potential risks of these substances and take any appropriate management actions regarding them.

Final Test Rule for the Second Group of HPV Unsponsored Chemicals (HPV2)

On January 7, 2011, EPA issued a second final test rule to require manufacturers of an additional 19 HPV chemicals to conduct testing on the health and environmental effects of these chemicals and submit the data to EPA. Note that EPA has published a technical correction to this rule.

The 19 chemicals in the second HPV test rule announced October 21, 2011, under Section 4 of TSCA have a wide variety of consumer and industrial applications. For example, diphenylmethanone is used in consumer products and may be found in personal care products, and 9, 10-anthracenedione is used to manufacture dyes.

Final Test Rule for the Third Group of HPV Unsponsored Chemicals (HPV3)

On February 25, 2010, EPA proposed a third test rule that would require manufacturers and processors of 29 HPV chemicals listed in the proposed rule to conduct environmental fate, ecotoxicity, acute toxicity, genetic toxicity, repeated dose toxicity, and developmental and reproductive toxicity testing.

On October 21, 2011, EPA issued a final test rule under TSCA section 4(a)(1)(B) to require manufacturers, importers, and processors of 15 HPV chemical substances to conduct testing to obtain screening level data for health and environmental effects and chemical fate. EPA has determined that each of the 15 chemical substances included in this final rule is produced in substantial quantities and that there is or may be substantial human exposure to each of them.

Moreover, EPA believes that there are insufficient data to reasonably determine or predict the effects on human health or on the environment from the manufacture, distribution in commerce, processing, use, or disposal of these chemicals, or from any combination of these activities. EPA has concluded that this testing program is needed and appropriate for developing such data.

Data developed under this final rule will provide critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and to take appropriate action.

Those who export or intend to export any chemical substance included in the final rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D. EPA has also taken steps to consider animal welfare and to provide instructions on ways to reduce or in some cases eliminate animal testing, while at the same time ensuring that public health is protected.

Proposed Test Rule and SNUR for the Fourth Group of HPV Unsponsored Chemicals (HPV4)

The 45 chemicals in these two rules are the remaining chemicals that were not sponsored during the HPV Challenge Program.

While 23 of the chemicals meet the exposure findings required to include them in a test rule, the 22 chemicals included in the SNUR do not meet those exposure findings. For those remaining 22 chemicals, the proposed SNUR designates “use in a consumer product” and “any use or combination of uses that is reasonably likely to expose 1,000 or more workers at a single corporate entity (defined as the aggregate of all of the domestic facilities owned or operated by an individual corporation)” as significant new uses.

The proposed SNUR would require filing a significant new use notice (SNUN) with EPA prior to manufacturing, importing or processing any of the 22 chemicals included in the SNUR for either of the significant new uses.

The proposed test rule would require manufacturers and processors of the 23 HPV chemicals to develop screening-level health, environmental, and fate data as outlined in the test rule based on potential for substantial exposures of workers and consumers to these chemicals.

Another regulatory option exists to collect health and environmental effects data for those unsponsored HPV chemicals for which statutory findings under TSCA Section 4 cannot readily be made. EPA can request that the Interagency Testing Committee (ITC) add the chemicals to the TSCA Section 4(e) Priority Testing List. Based on the ITC listing, the Agency can then include the chemicals in a TSCA Section 8(a) Preliminary Assessment and Information Reporting (PAIR) rule and a TSCA Section 8(d) Health and Safety Data Reporting (HaSDR) rule.

Section 8(a) PAIR rules require producers and importers to submit to EPA one-time reports on production/importation volumes, end uses, and exposure-related data for the listed chemicals. Section 8(d) rules require producers and importers to submit to EPA copies and lists of certain types of unpublished health and safety studies for the listed chemicals to EPA. Submitters under the 8(d) rule are also requested to provide robust summaries of health and environmental effects studies. Upon the receipt of 8(d) rule data, EPA will review all submitted chemical information for adequacy and makes robust summaries of submitted data publicly available through HPVIS. Should information for any chemicals still be inadequate, EPA can evaluate PAIR rule data and other data to determine if it can be used to make findings for a TSCA Section 4 test rule.

A TSCA Section 8(a) rule (71 FR 47122) and a TSCA Section 8(d) rule (71 FR 47130) were issued on August 16, 2006, for 243 HPV chemicals that were not sponsored in the voluntary portion of the HPV Challenge Program. EPA later withdrew 33 of these chemicals from both the 8(a) PAIR and the 8(d) HaSDR rules in a final rule issued on September 29, 2006 (71 FR 57439). In a subsequent direct final rule issued on April 30, 2007, EPA removed two additional chemicals from the 8(a) PAIR and the 8(d) HaSDR rules (72 FR 21119). EPA is also initiating actions, such significant new use rules (SNUR), to manage risks from HPV unsponsored chemicals.